FDA Approves Fixed-Dose Dapagliflozin, Saxagliptin for T2D

Qtern tablets are approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

AstraZeneca announced that the Food and Drug Administration (FDA) has approved Qtern (dapagliflozin and saxagliptin) tablets as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin 10mg or who are already treated with dapagliflozin and saxagliptin. Qtern should only be used in patients who tolerate dapagliflozin 10mg.

Qtern combines dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.  By inhibiting SGLT-2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Saxagliptin slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.

The approval of Qtern was supported by data form a Phase 3, 24-week, multi-center, randomized, double-blind, placebo-controlled trial (n=315) that evaluated the safety and efficacy of saxagliptin added to dapagliflozin in adults with type 2 diabetes who experienced inadequate glycemic control (HbA1c ≥7 to ≤10.5%) with metformin (≥1500mg daily). 

The safety of the combined use of dapagliflozin and saxagliptin has been evaluated in a pooled safety analysis (n=1,169) of three Phase 3 placebo-controlled trials for up to 52 weeks. 

Qtern will be available as 10mg/5mg strength tablets in 30-, 90-, and 500-count bottles.

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FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes [news release]. Wilmington DE: Astra Zeneca Press Office; February 28, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/fda-approves-once-daily-qtern-dapagliflozin-and-saxagliptin-tablets-for-adults-with-type-2-diabetes-240217.html. Accessed March 1, 2017. 

This article originally appeared on MPR